目的 研究脑心清片治疗高斑块负荷颈动脉粥样硬化（双侧颈动脉Crouse斑块总积分≥3分）患者颈动脉斑块的临床有效性及安全性。方法 选取2021年7月—2024年10月于北京市隆福医院确诊的高斑块负荷颈动脉粥样硬化患者42例，随机分为观察组（n＝28）和对照组（n＝14），分别给予脑心清片和阿托伐他汀钙片治疗，疗程均为6个月，比较两组患者的双侧颈动脉斑块的长度、斑块积分、斑块厚度、中医眩晕证候评分及不良反应。结果 治疗前，两组双侧颈动脉斑块长度比较，差异无统计学意义（P＞0.05），观察组患者治疗3个月后斑块长度显著低于对照组［（7.71±5.63） mm vs（13.25±8.46） mm，P＜0.05）］，且与治疗前相比，观察组患者治疗6个月后双侧颈动脉斑块长度均显著降低（P＜0.05）。治疗前后两组患者的斑块积分和斑块厚度的差异均无统计学意义（P＞ 0.05），观察组和对照组高脂血症亚组患者［低密度脂蛋白-胆固醇（LDLC） ＞3.1 mmol·L^-1）］治疗3个月后的斑块厚度呈降低趋势，但未达到统计学意义（P＞0.05）。治疗前，两组中医眩晕证候评分比较，差异无统计学意义（P＞0.05），与治疗前相比，观察组患者治疗1、3、6个月的中医眩晕证候评分均显著降低（P＜0.05），与治疗前比较，对照组治疗后6个月后中医眩晕证候评分显著降低（P＜0.05）。两组患者不良反应的发生率无统计学差异（P＞0.05）。结论 脑心清片治疗高斑块负荷颈动脉粥样硬化患者对颈动脉斑块有良好疗效，可缩短双侧颈动脉斑块长度，降低伴有高脂血症患者的颈动脉斑块厚度，减轻患者眩晕症状，临床应用安全性好。

Objective To investigate the clinical efficacy and safety of Naoxinqing Tablets in the treatment of carotid atherosclerosis with high plaque burden (bilateral carotid Crouse plaque total score ≥ 3 points). Methods A total of 42 patients with high plaque burden carotid atherosclerosis diagnosed at Beijing Longfu Hospital from July 2021 to October 2024 were selected and randomly divided into an observation group (n = 28) and a control group (n = 14). The observation group was treated with Naoxinqing Tablets, while the control group was treated with Atorvastatin Calcium Tablets. The treatment course for both groups was six months. The bilateral carotid plaque length, plaque score, plaque thickness, traditonal Chinese medicine (TCM) vertigo symptom score, and adverse reactions were compared between the two groups. Results Before treatment, there was no statistically significant difference in bilateral carotid plaque length between the two groups (P > 0.05). After three months of treatment, the plaque length in the observation group was significantly lower than that in the control group [(7.71 ±5.63) mm vs (13.25 ±8.46) mm, P < 0.05]. Compared with before treatment, the bilateral carotid plaque length in the observation group was significantly reduced after six months of treatment (P < 0.05). There were no statistically significant differences in plaque score and plaque thickness between the two groups before and after treatment (P > 0.05). However, in the hyperlipidemia subgroup [low-density lipoprotein-cholesterol (LDL-C) > 3.1 mmol·L^-1] of both the observation and control groups, plaque thickness showed a decreasing trend after three months of treatment, but the difference was not statistically significant (P > 0.05). Before treatment, there was no statistically significant difference in TCM vertigo symptom scores between the two groups (P > 0.05). Compared with before treatment, the TCM vertigo symptom scores in the observation group were significantly decreased at one, three, and six months of treatment (P < 0.05), and in the control group, the score was significantly decreased at six months after treatment compared with baseline (P < 0.05). There was no statistically significant difference in the incidence of adverse reactions between the two groups (P > 0.05). Conclusion Naoxinqing Tablets have good therapeutic effects on carotid atherosclerosis patients with high plaque burden, can reduce bilateral carotid plaque length, decrease carotid plaque thickness in patients with hyperlipidemia, alleviate vertigo symptoms, and demonstrate good safety in clinical application.

R972

中国博士后科学基金（2023M740790）；广州市青年人才托举工程项目（QT20220101283）